Clinical trial

Assessment of Adherence, Quality of Life, Clinical Response and Safety of Daily and Long-Acting Growth Hormone Therapy

ID

Name

PEDS-2020-28945

Description

The purpose of the study is to compare quality of life, adherence, insulin resistance, body composition and efficacy of long-acting growth hormone (LAGH) to daily growth hormone (DGH) in children with growth hormone deficiency (GHD). These objectives will be evaluated every 6 months for subjects prior to switch from DGH to LAGH, and 6 months after.

Trial arms

Trial start

2021-08-05

Estimated PCD

2024-10-01

Trial end

2024-10-01

Status

Recruiting

Treatment

Long-Acting Growth Hormone (LAGH)

Long-acting growth hormone (LAGH) treatment

Arms:

Transition to long-acting growth hormone (LAGH)

Size

80

Primary endpoint

Change in Insulin Resistance

Every six months for approximately 2 years

Change in Bone Mineral Density - DXA

Every six months for approximately 2 years

Change in Bone Mineral Density - pQCT

Every six months for approximately 2 years

Change in Percent Fat

Every six months for approximately 2 years

Change in Fat Free Mass

Every six months for approximately 2 years

Change in Muscle Content - DXA

Every six months for approximately 2 years

Change in Muscle Content - pQCT

Every six months for approximately 2 years

Eligibility criteria

Inclusion Criteria: * Girls must be between the ages of 2 and 11 years, and boys must be between the ages of 2 and 13 years * Have established diagnosis of pediatric growth hormone deficiency (GHD). For the purposes of the study, GHD is defined as peak growth hormone response to clonidine/arginine stimulation testing of \<10 ng/mL * Either treatment-naive or currently treated with a daily growth hormone as approved by health insurance Exclusion Criteria: * Any medical condition which, in the opinion of the Investigator, can be an independent cause of short stature and/or limit the response to exogenous growth factor treatment * Current treatment with long-acting growth hormone * Currently pregnant or breastfeeding

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood serum samples for Growth Hormone Antibodies will be stored in the freezer storage of the M Health Fairview University of Minnesota Medical Center.'}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}

Updated at

2023-07-27

1 organization

1 product

2 indications

Organization

University of Minnesota

Product

Long-Acting Growth Hormone

Indication

Growth Hormone Deficiency

Indication

Growth Hormone Treatment